Home / 510(k) Clearances / K071338

510(k) K071338

FLEX ARM RETRACTOR SYSTEM by Koros USA, Inc. — Product Code GZT

K071338 is an FDA 510(k) premarket notification submitted by Koros USA, Inc. for the device "FLEX ARM RETRACTOR SYSTEM". The FDA issued a decision of Substantially Equivalent on May 29, 2007. The device falls under product code GZT (Retractor, Self-Retaining, For Neurosurgery), a Class II device regulated under 21 CFR 882.4800. Koros USA, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2007
Date Received
May 14, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Retractor, Self-Retaining, For Neurosurgery
Device Class
Class II
Regulation Number
882.4800
Review Panel
NE
Submission Type

Other clearances by Koros USA, Inc.

  • K120590 — DILATOR TUBE SET (May 7, 2013)
  • K101609 — SELF RETAINING SOFT TISSUE RETRACTOR (December 9, 2010)
  • K082399 — PECTUS STRUT (November 5, 2009)

Other clearances for product code GZT

  • K210615 — Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clam (May 13, 2022)
  • K202694 — Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (January 14, 2021)
  • K202072 — MindsEye Expandable Port (August 26, 2020)
  • K180610 — Geister retractor for neuro - and spine surgery (August 29, 2018)
  • K172433 — NICO BrainPath (September 7, 2017)
  • K161680 — MEDICON Spinal Spreading Systems (March 24, 2017)
  • K161318 — Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological (March 20, 2017)
  • K161004 — Self-retaining Retractor (September 9, 2016)
  • K150378 — NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook (June 12, 2015)
  • K120691 — BRAIN PORT (June 5, 2012)

FDA data resources